NUHYDRASHIELD 30 SPF-30 SUNSCREEN- octisalate, octocrylene, avobenzone cream

NuHydraShield 30 SPF-30 Sunscreen by

Drug Labeling and Warnings

NuHydraShield 30 SPF-30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENTS

Octisalate 5.00%
Octocrylene 5.00%
Avobenzone 3.00%

Purpose

Sunscreen

USES:

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS:

• For external use only.

Do not use 

• on damaged or broken skin.

When using this product 

• keep out of eyes. Rinse with water to remove.

Stop use and consult physician 

• if irritation or rash develops.

Keep out of reach of children.

• If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

• Apply liberally 15-minutes before sun exposure.
• Reapply:

- At least every two-hours.
- Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other  sun protection measures including:

- Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
- For children under 6-months, consult a physician.

OTHER INGREDIENTS:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Daucus Carota Sativa (Carrot) Extract, Hyaluronic Acid, Isostearyl Palmitate, Laureth-7, Parfum (fragrance), Phenoxyethanol,
Polyacrylamide, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium PCA, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triethanolamine.

OTHER INFORMATION:

• Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

NUHYDRASHIELD 30 SPF-30 SUNSCREEN 
octisalate, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70859-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCONUT OIL (UNII: Q9L0O73W7L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CARROT (UNII: L56Z1JK48B)
HYALURONIC ACID (UNII: S270N0TRQY)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POMEGRANATE (UNII: 56687D1Z4D)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70859-052-01	120 mL in 1 TUBE; Type 0: Not a Combination Product	09/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/10/2019

Labeler - NuCare Pharmaceuticals,Inc. (010632300)